BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CERAMIC FEMORAL HEAD 28/-3MM T1

    MDR report key: 6960716 · Received October 19, 2017

    Report

    Report Number
    3002806535-2017-00898
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    May 21, 2017
    Report Date
    January 25, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK131684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF BIRTH - (B)(6). UNIQUE IDENTIFIER (UDI) # - (B)(6). CONCOMITANT PRODUCT(S): EP-105883, EPOLY 28MM RLC LNR MROM SZ23, 166560. A 14-103652, UNIV 2-HOLE SHL 52MM LNR SZ 23, 132750. A 51-106100, TPRLC 133 MP TYPE1 PPS SO 10.0, 3674056. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP CLOSE-REDUCTION DUE TO DISLOCATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    CLOSED REDUCTION DUE TO DISLOCATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741037 BIOLOX DELTA CERAMIC FEMORAL HEAD 28/-3MM T1 PROSTHESIS, HIP JDI BIOMET UK LTD. N/A 2015070101

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R